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NCT Number: NCT03215615

Evaluation of Two Resin Composites and Two Adhesives for a Novel Restorative Protocol to Treat Cervical Lesions

Non-carious cervical lesion is frequently associated with gingival recession, resulting in a combined lesion that has a different treatment prognosis when the two lesions appear alone. The literature presents few studies that propose a multidisciplinary approach (restorative and root coverage surgery procedures) to optimize the treatment of this combined lesion. The previously proposed approaches and materials have limitations and an optimal clinical protocol has not been established yet. Thus the aim of this study is to evaluate a novel multidisciplinary protocol with two resin composites and two different adhesive systems through a randomized clinical trial and laboratory studies. 120 combined lesions will be randomly assigned to one of the following groups: NP + TE (n = 30) - Partial restoration of cervical lesions with nanofilled composite and total-etch adhesive system and periodontal surgery for root coverage, NP + UA (n = 30) - partial restoration of cervical lesions with nanofilled composite and self-etching adhesive system and periodontal surgery for root coverage, MH + TE (n = 30) - partial restoration of cervical lesions with microhybrid composite and total-etch adhesive system and periodontal surgery for root coverage, MH + UA (n = 30) - partial restoration of cervical lesions with microhybrid composite and self-etching adhesive system and periodontal surgery for root coverage. Restorations will be assessed using the USPHS criteria after one week, six months and twelve months.

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Key information

Conditions

Dental Abrasion Composite Resins Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases Tooth Abrasion Tooth Diseases Tooth Wear

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UEPJMF

São José dos Campos, São Paulo, 12245000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals presenting one or more combined defect, i.e. a NCCL classified as B+ (Pini-Prato et al., 2010): presenting more than 1mm in depth, affecting dental crown and root associated with Miller's class I or II gingival recession in canines or premolars with pulp vitality;
  • Healthy patients (systemically and periodontally), 18 years old, with at least 20 teeth in occlusion;
  • Plaque index ≤ 20% (Ainamo & Bay, 1975);
  • NCCL cavo-surface margin without involvement of more than 50% of enamel;
  • In tooth included in the study and the adjacent elements of the following must be observed: probing depth less than 3 mm; do not show bleeding on probing (periodontal health) and no insertion loss in the proximal and palatal areas; Provide formal consent to participate in research, after the explanation of the risks and benefits by an individual not involved in it (Resolution #196 October 1996 and the Code of Dental Professional Ethics - C.F.O. - 179/93).

Exclusion criteria

  • NCCL previously restored;
  • Presence of caries;
  • Patients with periodontitis;
  • Patients with bruxism or teeth clenching;
  • Patients with orthodontic treatment in progress;
  • Pregnant patients or smokers;
  • Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, diabetes and others), which contraindicate the surgical procedure; Previous periodontal surgery in the area of interest of the present study.

Treatment and study plan

Periodontal surgery

Procedure

Coronally advanced flap for root coverage

Total Etch adhesive

Procedure

Total-etch adhesive system (two step)

Universal Adhesive

Procedure

One-step self-etching adhesive system

Nanofilled Composite

Procedure

Partial nanofilled-resin composite restoration

Micro-Hybrid Composite

Procedure

Partial micro-hybrid composite restoration

Primary outcomes

  1. Modified United States Public Health Service (USPHS) criteria

    Time frame: 1 year

    USPHS criteria is based on the following ratings: Color compatibility, retention, marginal adaptation, anatomic form, surface texture, marginal discoloration, sensibility pre-operative and postoperative and the presence of secondary caries

Secondary outcomes

  1. Aesthetics (Visual Analogue Acale - VAS)

    Time frame: 1 year

    The esthetics of the treatment will be evaluated by patients´ point of view using the VAS scale

  2. Dentin Hypersensitivity (Visual Analogue Acale - VAS)

    Time frame: 1 year

    The Dentin Hypersensitivity will be evaluated by patients´ point of view using the VAS scale

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

Evaluation of Two Resin Composites and Two Adhesives for a Novel Surgical-restorative Protocol for the Treatment of Non-carious Cervical Lesions Associated With Gingival Recession: a Randomized Controlled Clinical Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2017
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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